Sandoz Moves Its Biosimilar Development Strategy Forward
Sandoz, the generics division of Novartis, is currently the world leader in the biosimilar market. In fact, if it was not for Sandoz, the biosimilar industry may never have gotten started in the first place! As some of you may know, Sandoz sued FDA (and won) to gain approval of its biosimilar human growth hormone. While FDA contends that Omnitrope is not really a biosimilar (it was approved as a “drug” rather than a biologic) most analysts agree that it was the first biosimilar product ever approved and sold in the US.
As part of its global biosimilar strategy, Sandoz today announced that it had initiated Phase III clinical trails for US approval of biosimilar version of recombinant human granulocyte-colony stimulating factor(G-CSF) or filgrastim (Amgen’s Neupogen®) and another for global launch of PEG-filgrastim (Amgen’s Neulasta®); a PEGylated form of G-CSF.
The filgrastim study is designed to evaluate the efficacy and safety of Sandoz's biosimilar filgrastim versus Neupogen® in breast cancer patients eligible for myelosuppressive chemotherapy treatment. These trials expected to support extension of commercialization to the US, the largest global market for biologics. The pegfilgrastim study, which is being conducted in breast cancer patients undergoing myelosuppressive chemotherapy treatment, represents the next major step in the Sandoz global biosimilar development program. Previously, Sandoz announced that it had initiated late stage clinical trials for a biosimilar version of Roche’s monoclonal antibody cancer treatment Rituxan®). Finally, Sandoz has eight to ten different biosimilar molecules at various stages of development in its pipeline.
Sandoz currently markets and sells three biosimilars: filgrastim (Zario®), somatropin (Omnitrope®) and epoetin alfa (Binocrit®) in countries across Europe and elsewhere. As mentioned above Omnitrope is also sold in the US. However, because FDA has yet to craft a regulatory approval pathway for biosimilars (despite legislation mandating their approval) it is illegal to sell biosimilars (with the exception of Omnitrope) in the US.
Once vilified and staunchly opposed by most major pharmaceutical and biotechnology companies, the biosimilar business has been picking up steam in the past few years. To that end, companies like Merck, Pfizer, Teva and more recently Amgen and Biogen (all of whom lobbied against an approval pathway for biosimilars in the US) announced plans to compete on the global biosimilar market.
The decision of these companies to enter the biosimilar market is largely a result of downward pricing pressures on pharmaceutical and biotechnology drugs and near-empty drug pipelines at most major life sciences companies. Nevertheless, it is still not clear whether or not a robust biosimilar market truly exists. To wit, biosimilars have been in the market in the EU for the past fiver years and have not gained much traction there. However, the real biosimilar markets probably exist in China, Brazil and other emerging countries where there are large populations and emerging middle classes but drug prices are under tight government regulation. Because of this, the uptake of biosimilars in these markets will likely be greater than in Europe and the US.
Until next time...
Good Luck and Good Job Hunting!!!!!!!!!!!!!!!
I have been in the business long enough to remember when Amgen was the largest and most successful biotechnology company in the world. During most of the 90s and early 2000s, Amgen was second to none. But, a lack of innovation, questionable marketing practices and an uncreative executive management team forced the once invincible biotech Giant to recently stumble and relinquish its world class status.png)
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Remember when Amgen was the world’s largest and most profitable biotechnology company? That was way back in 2006 before its marketing and sales team got in trouble for “pushing” the sale of its erythropoietin (EPO) product Epogen and Aranesp beyond acceptable patient safety limits. This, along with a relatively thin new drug pipeline, has for the past five years or so relegated the company to second tier biotech company status.
Bloomberg news today 
While India and China have been getting much of the attention and press over the past few years, Latin America is quietly become a market to watch for the life sciences industry. According to industry analysts,
Five years ago Amgen was the world’s largest biotechnology and was, by many accounts, the darling of Wall Street. But, today, there is little mention of the once formidable biotechnology company that many startups attempted to emulate. Like other companies, Amgen ran into pipeline problems, medical issues with existing blockbuster drugs (remember the whole hematocrit brouhaha over Epogen and Aranesp its flagship anemia products), lower drug sales and ultimately the perception that the company had lost its innovative edge. However, it now appears that Amgen is making something of a comeback and may have been quietly preparing itself for its “rebirth” over the past few years..jpg)
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It’s official! Roche has secured more than 96 percent of shares in Genentech Inc, completing its $46.8 billion buyout of the U.S. biotech group. It now holds some 93 percent of outstanding Genentech shares, a further 3 percent are guaranteed to be delivered within the next three business days and it will integrate the U.S. biotech group as soon as possible.
Pfizer is the largest pharmaceutical company in the world. It was able to garner that distinction by going on a decade-long buying spree that began in the mid 1990s. To date, Pfizer has acquired Warner Lambert, Pharmacia and a host of smaller specialty pharmaceutical and biotechnology companies. Despite these acquisitions, which yielded top selling blockbuster drugs like Lipitor and Celebrex, Pfizer’s stock has never performed up to analyst’s expectations. In fact, while it’s smaller and more nimble pharmaceutical competitor’s stock prices were soaring, Pfizer’s stock price was either flat or falling. While conventional wisdoms suggest that “bigger is always better” this has proven not to be the case when companies, like Pfizer, attempt to win greater market share through mergers and acquisition and also loss sight of their core business.
After beating Wall Street expectations and disclosing positive results from an osteoporosis (densomab) clinical trial, .jpg)
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Last year was a 
Each year Fortune publishes a list of the top 100 companies that it believes are the best to work for. A quick perusal of the 
In 2004, the European Commission adopted a new directive that paved the way for legal approval of biosimilars in the European Union (EU). To date, five (5) biosimilars have garnered marketing approval in the EU. Of the five, two are generic versions of recombinant growth hormone (rHGH)–Omnitrope (Sandoz) and Valtropin (Biopartners). .jpg)
The European commission is expected to grant marketing approval for the product in the EU. The product, developed by Israel-based Teva, a global generics manufacturer, will be sold under the brand name TevaGrastim. The company is seeking EU approval for TevaGrastim a as treatment of chemotherapy-induced neutropenia. 
Until recently, Amgen dominated the biotechnology industry and was anointed the world's largest biotechnology company. However, Amgen recently lost its number 1 ranking to Genentech. Over the past year or so, Amgen, which is now ranked number 2, has been acting a lot like Avis, the car rental company , which in the 1970s adopted the slogan “Avis: We Try Harder” when it was number 2 to Hertz in the car rental rankings. Like Avis, which never overtook Hertz to claim the number 1 spot, Amgen’s efforts to regain its number 1 ranking are failing.
According to Johnson & Johnson, a panel of advisors for the Food and Drug Administration, in a surprise decision, supported keeping Epogen, Procrit and Aranesp from Amgen and Johnson & Johnson on the market for use in cancer patients who are anemic from chemotherapy.
Erythropoietin (EPO) is a hormone (protein) that regulates red blood cell production in humans. Back in the 1980s, scientists at a fledgling biotechnology company called Amgen determined that recombinant EPO was highly effective for treating anemia. Amgen owned the intellectual property rights to the EPO gene and decided to sell the recombinant protein encoded by EPO (called epoetin) as a treatment for anemia.
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A federal judge ruled that Amgen.jpg)
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Still reeling from lawsuits filed last week by ex-sales reps’ alleging improper marking of Enbrel to treat patients with psoriasis, Amgen was subpoenaed on Monday by New Jersey's attorney general regarding allegations that the company promoted Enbrel for unapproved uses.
As many of you know, the pharmaceutical industry has been trending downward for the past year or so. Weak pipelines, uncontrolled corporate expansion and soaring drug prices have been offered to explain the recent down turn. However, the real back story to the downturn is the loss of future revenues that is expected to occur starting in 2010 when many current blockbuster pharmaceutical products, 
It goes without saying that Amgen has had a run of bad luck over the past six months. But, just when you thought things couldn’t get much worse, two former Amgen sales representatives are suing the company, alleging it pushed its sales force to search doctor's confidential medical records for potential patients to boost sales of its blockbuster drug .jpg)
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As the debate continues to rage in the US about how to regulate biogeneric drugs, the European Medicines Agency (EMEA) has given the .jpg)
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Swiss pharmaceuticals producer Roche Holding AG said Thursday
A sharp drop in sales of its blockbuster diabetes medication 
First, there was the 
This should not come as a big surprise (especially to the Amgen employees who already know that they will be losing their jobs) but .jpg)
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I posted a piece 
